Safety and efficacy of opicinumab in patients with relapsing multiple sclerosis (SYNERGY): a randomised, placebo-controlled, phase 2 trial

This study is registered at ClinicalTrials.gov, number NCT01864148.FindingsBetween Aug 13, 2013, and July 31, 2014, 419 patients were enrolled and randomly assigned either placebo (n=93) or opicinumab 3 mg/kg (n=45), 10 mg/kg (n=95), 30 mg/kg (n=94; one patient did not receive the assigned treatment), or 100 mg/kg (n=92). The last patient visit was on March 29, 2016. Confirmed disability improvement over 72 weeks was seen in 45 (49%) of 91 patients assigned to placebo, 21 (47%) of 45 assigned to opicinumab 3 mg/kg, 59 (63%) of 94 assigned to opicinumab 10 mg/kg, 59 (65%) of 91 assigned to opicinumab 30 mg/kg, and 36 (40%) of 91 assigned to opicinumab 100 mg/kg. A linear dose-response in the probability of confirmed disability improvement was not seen (linear trend test p=0·89). Adverse events occurred in 79 (85%) patients assigned placebo and in 275 (85%) assigned any dose of opicinumab. The most common adverse events of any grade in patients assigned any dose of opicinumab included influenza-like illness (140 [43%] with any dose of opicinumab vs 37 [40%] with placebo), multiple sclerosis relapses (117 [36%] vs 30 [32%]), and headache (51 [16%] vs 23 [25%]). Serious adverse events reported as related to treatment were urinary tract infection in one (1%) participant in the the placebo group, suicidal ideation and intentional overdose in one (1%) participant in the 30 mg/kg opicinumab group, bipolar disorder in one (1%) participant in the 100 mg/kg opicinumab group, and ...
Source: The Lancet Neurology - Category: Neurology Source Type: research

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Authors: Guillaume GM, Vuylsteke ME, Dalcq V, Van der Borght L, Meeus P, de Maeseneer MG Abstract BACKGROUND: To date, it is unclear how treatment of patients with chronic venous disease (CVD) is influenced by national reimbursement systems. In Belgium, catheters or fibers used for endovenous thermal ablation (EVTA) are reimbursed only once in a lifetime. The potential impact of the Belgian public health insurance reimbursement policy on surgical practice in phlebology needs to be investigated. METHODS: Billing data available from the Belgian National Institute for Health and Disability Insurance (NIHDI) were u...
Source: International Angiology - Category: Cardiology Tags: Int Angiol Source Type: research
Publication date: Available online 21 February 2020Source: Antiviral ResearchAuthor(s): Rashmi Kumari, Zhu Guo, Amrita Kumar, Mayim Wiens, Shivaprakash Gangappa, Jacqueline M. Katz, Nancy J. Cox, Renu B. Lal, Devanand Sarkar, Paul B. Fisher, Adolfo García-Sastre, Takashi Fujita, Vijay Kumar, Suryaprakash Sambhara, Priya Ranjan, Sunil K. LalAbstractInfluenza virus non-structural protein 1 (NS1) counteracts host antiviral innate immune responses by inhibiting Retinoic acid inducible gene-I (RIG-I) activation. However, whether NS1 also specifically regulates RIG-I transcription is unknown. Here, we identify a CCAAT/Enh...
Source: Antiviral Therapy - Category: Virology Source Type: research
Publication date: April 2020Source: Fish &Shellfish Immunology, Volume 99Author(s): Zhichu Chen, Diana Ceballos-Francisco, Francisco A. Guardiola, M. Ángeles EstebanAbstractThe effects of skin wounds on the intestinal barrier function and the beneficial effects of the dietary administration of Shewanella putrefaciens (known as SpPdp11) in gilthead seabream (Sparus aurata L.) were studied. Two replicates of fish were fed a commercial diet (control, CON) or CON diet enriched with 109 cfu g−1 SpPdp11 (SP diet) for 30 days. After this time, half of the fish were sampled, while the others were injured...
Source: Fish and Shellfish Immunology - Category: Biology Source Type: research
CONCLUSIONS: Given increasing rates of opioid addiction and death, viable solutions are universally needed. Successful intervention measures should be widely shared between military, veteran, and civilian healthcare and public health communities. Increased collaboration between these groups could inculcate successful programs to prevent and decrease opioid use. Results received from recent military and veterans' programs for prescription and electronic medical record (EMR) monitoring and data sharing may also prove useful for civilian healthcare providers and hospital systems. Future evaluations from ongoing federally fund...
Source: Military Medicine - Category: International Medicine & Public Health Tags: Mil Med Source Type: research
Authors: Shiroma PR, Velasquez T, Usset TJ, Wilhelm JH, Thuras P, Baltutis E Abstract INTRODUCTION: Obesity is prevalent among users of Veteran's Health Administration services, where it is comorbid with depression, post-traumatic stress disorder, type 2 diabetes, cardiovascular disease, colon, and breast cancer. Among obese subjects, severe obesity represents a subpopulation with the highest risk of depression. We investigate the antidepressant effect of a local VA weight management program (Managing Overweight Veterans Everywhere - MOVE) among depressed veterans with severe obesity. MATERIAL AND METHODS: In a...
Source: Military Medicine - Category: International Medicine & Public Health Tags: Mil Med Source Type: research
CONCLUSION: Findings suggest few soldiers-in-training are likely to seek help when experiencing a problem. General efforts to encourage help-seeking when needed are warranted with particular focus on subsets of soldiers-in-training (eg, men, those with a history of some adverse childhood experiences). Strengths of this study include the examination of a large sample of soldiers-in-training to identify possible leverage points for early intervention or prevention prior to entering stressful military operating environments. Limitations of this study include the examination of only one military branch and exclusion of soldier...
Source: Military Medicine - Category: International Medicine & Public Health Tags: Mil Med Source Type: research
This study examined treatment-related changes in depression, anger, and PTSD following cognitive processing therapy (CPT) as potential predictors of QOL change. MATERIALS AND METHODS: Data from two randomized controlled trials, one examining CPT among female civilians and veterans (women's study NCT02362477; n = 126) and the other on CPT delivered to male veterans (men's study NCT00879255; n = 125), were used to test study aims. Linear mixed modeling examined changes in depression, anger, and PTSD as predictors of post-treatment QOL while controlling for baseline QOL. The VA Pacific Island Health Ca...
Source: Military Medicine - Category: International Medicine & Public Health Tags: Mil Med Source Type: research
Authors: Kranz AM, Ross R, Sorbero M, Kofner A, Stein BD, Dick AW Abstract BACKGROUND: Integrating preventive oral health services (POHS) into medical offices may ease access to care for children with intellectual and developmental disabilities (IDD). The authors examined the impact of state policies allowing delivery of POHS in medical offices on receipt of POHS among Medicaid enrollees with IDD. METHODS: The authors used 2006 through 2014 Medicaid data for children with IDD aged 6 months through 5 years from 38 states. IDD were defined using 14 condition codes from Centers for Medicare &Medicaid Services ...
Source: Journal of the American Dental Association - Category: Dentistry Tags: J Am Dent Assoc Source Type: research
The objective of our work was to evaluate if the breakage of a dam containing wastefrom a mining cite in Brazil, in 2015, an environmental disaster popularly known as the Mariana Tragedy, affected the health of newborns exposed in utero. We used administrative data on birth records and reports on the Mariana Tragedy to identify all births from newborns exposed in utero and the intensity of that exposure, according to the mother's municipality of residence. Using a difference-in-differences framework, we estimated the impact of different intensities of exposure on birth outcomes. We found that being directly exposed in uter...
Source: Social Science and Medicine - Category: Psychiatry & Psychology Source Type: research
ConclusionsOur study demonstrates a differential association between ACEs and anxiety and depression. Thus, highlighting the importance of assessing the impact of ACEs on internalizing behaviors separately. These findings are significant for pediatric providers as diagnosis and treatment for mental health disorders are a vital component of pediatric care and further supports the American Academy of Pediatrics recommendation to screen for ACEs.
Source: Academic Pediatrics - Category: Pediatrics Source Type: research
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